16305, 36th Avenue North, Suite 300, Plymouth, Minnesota, 55446
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Edison System | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| HistoSonics® Planning Tool | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
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